1. Biosafety and Bioethics Dr. Sarah bukhari Ass.Prof. pharmaceutical microbiology

2. Ancient Greek Chimera The Chimera was a hybrid monster of ancient Greek legend that was thought to live in southwest Anatolia (present-day Turkey).

3. OUTLINE New limits to the interference with life? How do we know what is acceptable? What are the concerns of the public? What will be considered ethically acceptable?

4. NEW LIMITS TO THE INTERFERENCE WITH LIFE?

5. NEW LIMITS TO THE INTERFERENCE WITH LIFE? (1/2) During the last century scientists have made genuine progress in explaining and usefully modifying the processes of life Until recently, the main limits to interference with life were of a technical kind: what is possible to do? Increasingly scientists and industry are faced with ethical limits: what is acceptable to do?

6. NEW LIMITS TO THE INTERFERENCE WITH LIFE? (2/2) Breeding has changed domestic animals over thousands of years However, genetic changes were poorly understood until recently Modern genetics, scientific breeding schemes and others forms of biotechnology have increased our control With greater control comes greater responsibility

7. HOW DO WE KNOW WHAT IS ETHICALLY ACCEPTABLE?

9. Basic ethical principles Major Ethical Principles. secondary Ethical Principles.

10. Major Ethical Principles Non-maleficence Beneficence Autonomy Justice

11. Secondary Ethical Principles truth tellingfidelity and promise keepingconfidentialityhow much harm can be justifiably risked to effect goodAttempt to avoid undesirable exceptions

12. Medical ethics Medical ethics is the study of moral values and judgments as they apply to medicine.

13. Medical issues ABORTION Vaccine controversy Cloning Gene therapy

14. WHAT ARE THE CONCERNS OF THE PUBLIC?

15. EUROPEAN ATTITUDES TO BIOTECHNOLOGY Since 1991 the Eurobarometer surveys have examined the attitudes of the European public In general the surveys show that members of the European public Differentiate between medical and agricultural applications Do not become more positive towards biotechnology the more they know about it Are most sceptical towards biotechnology when it is applied to animals or food-production

16. SHOULD BIOTECHNOLOGY BE ENCOURAGED? Eurobarometer 1996: Mean score in the EU Range from - 2 to + 2

17. WHAT WILL BE CONSIDERED ETHICALLY ACCEPTABLE?

18. THREE GROUPS OF CONCERNS Concern for animals –Animal welfare –Animal integrity Concern for environment/nature –Biodiversity Concerns for humans –Biosafety –Slippery slope concerns –Need for ”nature”

19. FEATHERLESS CHICKEN

20. BLIND HENS

21. BRINGING IN SCIENTIFIC UNCERTAINTY Some of the consequences for animal welfare of biotechnology can be foreseen However, many consequences are unforeseen; and researchers clearly tend to be much too optimistic A good example is cloning

22. WHAT WILL BE CONSIDERED ETHICALLY ACCEPTABLE? The debate must allow all concerns to be heard and discussed Given the widely shared sceptical views presented in this talk it will only be considered acceptable to use biotechnology if important benefits are at stake

23. What can we do with rDNA? “Pharming”: modify organisms to produce drugs or other usable materials (also xeno-technology) Research: designing model organisms GM agriculture: modify crops or animals for human consumption Gene therapy: modify genetic disease “Designer babies”: modify offspring Bio-weapons: modify biological agents

24. What can we do with rDNA?

26. ‘Biosafety’ means the need to protect human and animal health and environment from the possible adverse effects of the products of modern biotechnology BIOSAFETY BIOSAFETY

28. The Cartagena Protocol on Biosafety (CPB) Entered into force on 29 th December 1993 Seeks to lay down an internationally acceptable framework to provide for an adequate level of protection against the possible adverse effects on biodiversity and human health.

29. Basic Premises of CPB “Advance Informed Agreement” between Parties (AIA) Decision on the basis of scientific risk assessment Precautionary Principle

30. Lab safety Lab safety: Each laboratory should adopt Standard operational procedures from guidelines of the WHO according to the type of work being carried out in their lab by: identifying potential hazards, and specifies practices and procedures to eliminate or minimize such hazards. Such operational procedures should be logged and made available in form of Laboratory manual to protect workers, products, co-workers, lab support personnel and environment.

31. Safety practices should be applied throughout the testing process and this met by three main steps: Pre- analytical Analytical Post- analytical

32. 1. Pre- Analytical which include Specimen collection, Specimen preparation and Specimen transport. The accuracy of test results depends greatly on the quality of the specimen. Therefore, proper specimen collection, preparation and handling is essential for samples submitted to the laboratory for testing.

33. 2. Analytical which include testing: follow the safety rules when performing any test in the lab.

34. 3. Post- Analytical disposal: After testing, clean up working area and properly dispose of contaminated waste.

35. Also known as BMBL 5—Describes the Centers for Disease Control and Prevention/National Institutes of Health (CDC/NIH) guidelines for each BSL Appropriate work for each BSL is described with combinations of the following : Laboratory Practices and Techniques Standard Practices Special Practices Safety Equipment (Primary Barriers) Laboratory Facilities (Secondary Barriers) Biosafety in the Microbiology and Biomedical Laboratory

41. Thank you